Daiichi Sankyo Neuropathy 201
A Randomized, Double-Blind, Placebo and Active Comparator-Controlled Study of DS-5565 for Treatment of Neuropathic Pain Associated with Diabetic Peripheral Neuropathy
| Protocol | DS5565-A-U201 |
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| Identifier | DS5565-A-U201 |
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| UID | 82828a9d-1105-4428-851b-f47d6ac6fc58 |
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| Status | Done - Archived |
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| Phase | 2 |
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| Category | Diabetic Neuropathy |
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| Launch Year | 2011 |
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| NCT Number | - |
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| Created | 2011-11-04 13:07 |
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| Last Updated | 2011-11-04 13:07 |
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Description
Key Elements: Study drug DS-5565 is in the same class as Lyrica (pregabalin) There is a 1 in 7 chance of placebo. Study drug administration : 2 tablets 1 capsule in the AM and 2 tablets 1 capsule at bedtime. 9 Visits (After Randomization at Visit 2, visits are conducted weekly). $40 per visit. Subject will need to complete washout (10-14 days) of any prohibited pain medications (anticonvulsants, opioids, NSAIDs, benzodiazepines, tricyclic antidepressants, SNRIs) once labs are received and sujbect is deemed eligible to continue. HbA1c < 10.0% at screening
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